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6b Infectolab Borreliose Labor und Diagnostik engl ... - BCA-clinic

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Ihr kompetenter <strong>Labor</strong>partner<br />

www.infectolab.de<br />

Patient information:<br />

<strong>BCA</strong>-<strong>clinic</strong><br />

Betriebs GmbH & Co. KG<br />

Dr. med. Armin Schwarzbach<br />

Facharzt für <strong>Labor</strong>medizin<br />

<strong>Labor</strong>atory services and diagnosis for Lyme disease and possible<br />

co-infections<br />

- The detection of tick-borne infections makes high demands on laboratory analysis in<br />

combination with the diagnostic findings (anamnesis) -<br />

It is important to detect Borrelia infections at an early stage. The earlier the detection the simpler<br />

the treatment measures (usually antibiotics) and the shorter the ordeal of the infected patients.<br />

This is how you can diagnose Lyme Disease – a Lyme disease infection progresses in 3 stages depending on<br />

symptoms and ailments (time specification after the tick bite):<br />

1. Stage I<br />

(after days up to weeks): “bull’s eye rash“ (“Erythema chronicum<br />

migrans“, only in 40-70% of all cases), Borrelia lymphocytoma,<br />

headache, fever, sweating, “Summer flue“ (app. 20% of all<br />

cases), exhaustion and fatigue, facial palsy (especially with<br />

children/pupils).<br />

2. Stage II<br />

(after weeks up to months): inflammation of the brain; meninges;<br />

spinal marrow; any nerve in the human body, inflammations of<br />

the joints (“arthritis”), joint and muscle pain, inflammation of the<br />

eye, liver and kidneys, myocarditis, pericarditis, Cardiac<br />

arrhythmia.<br />

Borrelia burgdorferi – a<br />

spirochete bacteria with a range<br />

of over 300 proven species world<br />

wide.<br />

3. Stage III<br />

(after months up to years): Thinning of the skin at the back of the hand, (“Acrodermatitis chronica<br />

atrophicans“), Borrelia lymphocytoma (ear, nose, scrotum), lethargy, fatigue, paraesthesia, cognitive<br />

dysfunction, muscle inflammations, joint inflammations and swelling, tendon inflammations,<br />

inflammation of the bursa, vasculitis, myocardinal diseases, depression.<br />

Symptoms of Lyme disease occur in thrusts with alternating intensity and appearance in contrast<br />

to a classic organic illness. Many patients also suffer from slightly higher temperature during those<br />

thrusts. Co-infections with other bacteria and viruses have been increases over the past years and<br />

often lead to a complicated course of the disease. Often the tick bite is not detected early enough<br />

or the acute treatment by the attending physician is not sufficient. The chronic Lyme disease<br />

patients often go through a true “martyrdom” as they do not only suffer from actual physical and<br />

mental ailments, but also from not receiving a reliable diagnosis and the fact that their illness is not<br />

taken seriously.<br />

There are three main reasons why a Lyme infection is not immediately detected in daily practice,<br />

so that a treatment at an early stage is inhibited:<br />

1. There is no bull’s eye rash (“Erythema chronicum migrans“)! Research has proven that<br />

this classic symptom of Lyme disease only appears in 40% to a maximum of 70% of all<br />

cases.<br />

2. No tick bite detected! Such a bite can be induced even by very small ticks (larvae). Or it<br />

was not detected because there was no specific skin reaction. In addition, the scientific<br />

community now assumes that Borrelia bacteria can also be transmitted by infected insects.<br />

3. Only conventional blood tests have been performed. This was either too early<br />

(antibodies can be tested positive only after a period of up to six weeks after the tick bite)<br />

or there have been absolutely no antibody production in the body or the cellular stage was<br />

not or not sufficiently tested (necessary tests are: Elispot ® -LTT and CD3-/CD57+ cells).<br />

<strong>Infectolab</strong>, ein Geschäftsbereich der <strong>BCA</strong>-<strong>clinic</strong> Betriebs GmbH & Co. KG<br />

Geschäftsführer: Dr. med. Carsten Nicolaus, Dr. med. Armin Schwarzbach<br />

Amtsgericht Augsburg HRA 15697 · Morellstraße 33 · 86159 Augsburg · Tel. +49/ 0821/ 455 074-0 · Fax +49/ 0821/ 455 074-1<br />

www.infectolab.de · e-mail: service@infectolab.de · Umsatzsteuer-Ident.-Nr. DE250941023 · Bankverbindung:<br />

Kreissparkasse Augsburg (BLZ 720 501 01) · Konto-Nr. 19885 · IBAN: DE48 7205 0101 0000 0198 85 · BIC: BYLANDEM1AUG


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 2<br />

The <strong>BCA</strong>-<strong>clinic</strong> Augsburg (<strong>BCA</strong>) is specialised in the diagnosis and therapy of tick-borne<br />

diseases. In case of a suspected tick-borne disease the diagnosis is performed by experienced<br />

physicians of the “Medical Partnership” cooperating with the <strong>BCA</strong>-<strong>clinic</strong>. The diagnosis is based on<br />

an extensive anamnesis in which precise ailments and the antecedent are recorded and reviewed<br />

along with a physical examination (= <strong>clinic</strong>al findings). Additionally, the physician will initiate<br />

specific laboratory tests of your blood, which will be <strong>und</strong>ertaken and analysed in the specialised<br />

laboratory of the <strong>BCA</strong>-<strong>clinic</strong>.<br />

First the laboratory diagnosis is crucial for the detection<br />

of Borrelia. There is a difference between the tests of the<br />

humoral (antibodies) and cellular level (lymphocytes,<br />

NK-cells). Both levels have to be examined at the same<br />

time when a Lyme disease or an apparent illness is<br />

suspected.<br />

1. <strong>Labor</strong>atory testing of the humoral level (antibodies):<br />

Borrelia IgM- and IgG-EIA (Enzymimmuno-assay)<br />

as well as Borrelia IgM- and IgG-Immunoblot<br />

2. <strong>Labor</strong>atory-testing of the cellular level:<br />

Elispot ® -LTT (Borrelia Elispot Lymphocyte Transformation<br />

Test), CD3-/CD57+ cells (NK-cells)<br />

Explanations of these tests:<br />

1. Antibodies – humoral level: In case of the Borrelia antibodies<br />

examinations up to 19% of the antibodies results in the EIA are<br />

falsely negative due to the minimal sensitivity (responsiveness)<br />

of the EIA in contrast to the Immunoblot. Therefore it is<br />

essential to check the Borrelia IgM- and IgG-Immunoblot along<br />

with the Borrelia IgM- and IgG-EIA (even with a negative EIA)!<br />

Important: The laboratory has to always tests for VlsE (Variable<br />

major protein-like sequence Expressed) in EIA and<br />

Immunoblot. VlsE describes the characteristics of the Borrelia<br />

as a “chameleon“, which permanently changes the surface<br />

structure VlsE in vivo to resist the detection via the immune<br />

system. VlsE has the highest sensibility for the antibody search!<br />

Armin Schwarzbach M.D.,<br />

medical specialist for laboratory medicine,<br />

head of the <strong>BCA</strong> laboratory and<br />

specialist for Lyme and co-infections.<br />

Beware of positive antibodies constellations!<br />

Borrelia IgM- as well as IgG-antibodies can remain in the body for<br />

months or years even without an active Lyme disease infection.<br />

Hence a positive Borrelia antibodies test does not give any evidence<br />

of the activity of a Lyme infection, but gives only one conclusion: There must have been a tick bite or tick<br />

bites in the past during which Borrelia bacteria have been transmitted – no more or less!<br />

2. Cellular level:<br />

a) The Borrelia Elispot ® -LTT provides information about the current activity of the Borrelia bacteria and is<br />

20 to 200 fold more sensitive than a EIA-antibodies test.<br />

b) The CD57+ cells indicate the extent of immune suppression during a chronic Lyme disease and are the<br />

prognostic factor during and after the antibiotic treatment.<br />

The complete laboratory diagnosis is very complex and - considering the co-infections - has to be<br />

put together like a mosaic. This demands experienced Lyme disease analysts who can diagnose<br />

and evaluate all other infections as well.<br />

Armin Schwarzbach, M.D., PhD, is head of laboratory medicine and diagnostics in the <strong>BCA</strong>.-<strong>clinic</strong>.<br />

Dr. Schwarzbach is very experienced in laboratory medicine and has been a specialist in Lyme<br />

disease and co-infections for years.<br />

The medical laboratory diagnosis is primarily orientated on the guidelines of the German Society<br />

for Hygiene and Medical Microbiology (MiQ12 Lyme-<strong>Borreliose</strong>). However, the complexity of a<br />

Lyme disease infection is not sufficiently covered by this and needs additional laboratory testing.


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 3<br />

Therefore further internationally accepted methods are applied which are of considerable<br />

importance for the patient before and after the therapy (e.g. for the cellular level: Elispot ® -LTT and<br />

the CD3-/CD57+ cells).<br />

The laboratory integrated in the <strong>BCA</strong> for the analysis of vital parameters ensures, especially in the<br />

case of the medical treatment (e.g. infusion therapy), that the physicians of the medical<br />

partnership make further therapy decision as soon as possible according to the blood results.<br />

In practice, the following laboratory constellations indicate a Borrelia infection:<br />

(1) Positive antibody detection and positive cellular results<br />

(Elispot ® -LTT and/or CD57+) – often active infection<br />

(2) Positive antibody detection without positive cellular test findings – What kind of indications<br />

are shown by the <strong>clinic</strong>al findings (symptoms)?<br />

(3) Negative antibodies detection, but positive cellular test results<br />

- Indication for an active Lyme disease at an early stage, but also chronic stage – what<br />

kind of indications are shown by the <strong>clinic</strong>al findings (symptoms)?<br />

Attention: A negative antibody detection in the EIA and/or Immunoblot does not give evidence of<br />

a Lyme infection! Because: the antibodies production of a Lyme disease in stage I needs several<br />

weeks, 10 to 14 days at a minimum. Thus the immediate measurement of cellular activity in<br />

Elispot ® -LTT is a compulsory necessity, as normally the cellular activity precedes the humoral<br />

activity in stage I of a Lyme disease infection.<br />

In practice the following combinations of blood tests have proven useful:<br />

<strong>Labor</strong>atory diagnosis stage I<br />

(Costs: 393,44 € plus extra charges.)<br />

1. Borrelia IgG- and IgM-EIA incl. VlsE<br />

2. Borrelia IgG- and IgM-Immunoblot<br />

incl. VlsE<br />

3. Borrelia Elispot ® -LTT<br />

<strong>Labor</strong>atory diagnosis stage II and<br />

stage III (Costs app.: 544 € plus extra charges.)<br />

1. Borrelia IgG- and IgM-EIA incl. VlsE<br />

2. Borrelia IgG- and IgM-Immunoblot<br />

incl. VlsE<br />

3. Borrelia Elispot ® -LTT<br />

4. CD3-/CD57+ cells<br />

Necessary “Staging“ (evaluation of progression) of Lyme disease during and after an antibiotic or<br />

holistic approach to therapy: The above mentioned parameters also have to be checked during<br />

Lyme therapy.<br />

Recommended laboratory diagnosis during the therapy:<br />

Stage I<br />

Performance of above mentioned 3 tests<br />

4 weeks after beginning of therapy and 8<br />

weeks after the end of therapy.<br />

Stage II and III<br />

Performance of above mentioned 4 tests after<br />

beginning of therapy every 8 weeks as well as<br />

8 weeks after end of therapy.<br />

For explanation: Borrelia antibodies or titer cannot be “eliminated”, but they can exist in the<br />

blood for months or even years. After a successful antibiotic therapy Elispot ® -LTT as well as<br />

CD57+ cells should have come to a “normal” level 8 weeks after the end of therapy. But: Inspite<br />

of a symptom free status after treatment there might be still positive findings of Elispot ® -LTT<br />

and/or CD57+ cells, so the patient should be considered for a “monitoring” of the activity tests and<br />

possible future symptoms. Otherwise there will be the risk of a relapse, a new infection or a coinfection.<br />

It should be noted that laboratory parameters alone do not give a definite proof of Lyme disease,<br />

but very important evidence and details about a possible infection. The parameters are also very<br />

important to make decisions about the duration and success of therapy.


Adjoining is an overview<br />

of relevant diagnostic<br />

parameters of tick-borne<br />

diseases.<br />

These may be extended<br />

or limited individually<br />

during an extensive<br />

consultation meeting with<br />

your attending physician<br />

(e.g. in case of prefindings).<br />

Based on the coinfections<br />

questionnaire<br />

indications are<br />

established if such<br />

additional laboratory tests<br />

are necessary.<br />

An overview of prices can<br />

be fo<strong>und</strong> in the<br />

attachment “Order for<br />

laboratory tests with<br />

declaration of consent“ for<br />

patients.<br />

Note: The laboratory analysis is only one part<br />

of a comprehensive diagnosis. The <strong>clinic</strong>al<br />

report based on an extensive anamnesis and<br />

a physical examination is the crucial part. The<br />

experienced physicians of the cooperating<br />

Medical Partnership know the broad range of<br />

possible disease patterns, which can also<br />

become noticeable as „unspecific general<br />

symptoms“ (note adjoining chart).<br />

Generally, the laboratory diagnosis causes the following costs:<br />

<strong>Labor</strong>atory costs<br />

1. for Borrelia IgM- and IgG- antibodies including VLSE,<br />

Borrelia Elispot ® -LTT and CD3-/CD 57+ T-lymphocytes<br />

with blood sampling and special tubes app. 544 €<br />

2. Basic laboratory (blood count, liver-kidney-clotting) app. 80 €<br />

3. Possible necessary additional examination when suspicion of coinfections<br />

(Each test app. 61 – 97 €): up to app. 945 €<br />

Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 4<br />

infectolab laboratory diagnostic services: Special tests and know-how in detection<br />

of Lyme disease and possible co-infections<br />

Basis diagnosis Lyme disease Komplicating Viruses / Bacteria (Antibodies)<br />

Borrelia IgG-EIA (incl. VlsE) Herpes Simplex Virus-IgG/-IgM<br />

Borrelia IgM-EIA (incl. VlsE) Mycoplasma pneumoniae-IgG/-IgA/-IgM<br />

Borrelia IgG-Immunoblot (incl. VlsE) Epstein Barr-Virus-IgG/-IgM<br />

Borrelia IgM-Immunoblot (incl. VlsE) Chlamydia pneumoniae-IgG/-IgA<br />

Borrelia Elispot-LTT * Chlamydia trachomatis-IgG/-IgA<br />

CD3-/CD57+ -T-Lymphocytes Helicobacter IgG/-IgA<br />

Borrelia DNA-PCR Toxoplasmosis IgG/-IgM<br />

Yersinia IgG/-IgA<br />

Liver - kidney - blood count - electro-<br />

lyte - muscle - fats - hyperthyroidism Tick-borne Co-infections (Antibodies)<br />

" Organ profile " (Blood count, sGOT Ehrlichia-/Anaplasma-IgG/-IgM<br />

sGPT, sGGT, LDH, CHE, Bilirubin Babesia IgG<br />

total, Amylase, Lipase, CK, Creatinine Rickettsia IgG/-IgM<br />

Urea, Sodium, Potassium, TSH basal Bartonella IgG/-IgM<br />

Uric acid Tick-borne Co-infections/Viruses/<br />

Cholesterol, Triglycerides, HDL, LDL Bacteria (Activity tests)<br />

TSH basal, free T3, free T4 Ehrlichia/Anaplasma-Elispot-LTT *<br />

MAK, TAK, TRAK Chlamydia pneumoniae-Elispot-LTT *<br />

CRP Chlamydia trachomatis-Elispot-LTT*<br />

Autoantibodies Tick-borne Co-infections<br />

ANA titer (PCR direct detection)<br />

Anti-CCP Ehrlichia/Anaplasma<br />

c-/p-ANCA Barbesia microti<br />

C3-/C4- complement Bartonella henselae<br />

ENA Rickettsia<br />

ds-DNS Chlamydia in Sputum<br />

Mykoplasma in Sputum<br />

"Diarrhea / Celiac disease profile" Urine testing for heavy metals<br />

Antigliadinin-IgA-Antibodies, tissue- Aluminium, Cadmium, Lead<br />

transglutaminase-IgA-Antibodies, IgA Mercury, Copper, Creatinine<br />

* Lymphocytes Transformation Test<br />

Example: Range of services for laboratory tests for Lyme disease and possible co-infections (complete M3-<br />

<strong>Labor</strong>atory) All laboratory parameters of <strong>clinic</strong> chemistry, of infection serology, of autoimmune and hormone<br />

diagnostic as well as microbiology are also available.<br />

Note:<br />

• Elispot- and CD3-/CD57+ are principally not covered by health insurances!<br />

• The unit prices for different laboratory tests result from the laboratory order form in the attachment:<br />

blood samplings and special tubes will be billed separately.


<strong>Labor</strong>atory tests of possible co-infections<br />

Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 5<br />

<strong>Labor</strong>atory tests of possible co-infections have an increasing importance when adequate evidence<br />

exists (<strong>BCA</strong> co-infections sheet). Especially Ehrlichia/Anaplasma, Babesia, Bartonella, Rickettsia,<br />

Chlamydia and Mycoplasma are to be named.<br />

Because: numerous symptoms of the co-pathogens overlap the same symptoms of Lyme disease<br />

patients. Without an exact knowledge of a patient’s possible co-infections the therapist cannot<br />

make a exact decision about the antibiotic therapy. Not all co-infections can be treated by the<br />

generally used antibiotics for Lyme disease. However, the testing for co-infections can induce<br />

extensive additional laboratory costs (up to 945€). But these are justified by the additional security<br />

in the diagnosis and especially by the correct antibiotic decision, i.e. more success in antibiotic<br />

therapies as well as generally less expensive costs for medication during the antibiotic therapy<br />

(vs. the “classical” antibiotic therapy of chronic Lyme disease).<br />

Apart from the LTT for Borrelia further cellular activity tests for Ehrlichia/Anaplasma, Chlamydia<br />

pneunomiae and Chlamydia trachomatis have been developed in the meantime (Babesia cellular<br />

activity testing is coming soon) and can therefore be determined with Elispot-LTT-technique. With<br />

the help of this new Elispot ® -LTT many activities of Chlamydia and Ehrlichia have been detected<br />

in the <strong>BCA</strong>! A serum examination concerning co-infections is perfomed at the same time. There<br />

are now well standardised antibody tests for Chlamydia, Mycoplasma, Ehrlichia, Bartonella,<br />

Rickettsia, Babesia, Yersinia etc. The same applies here as well as with the Borrelia-LTT: the<br />

antibodies alone do not have any significance towards the activity of an infection – but the<br />

Elispot ® -LTT is significant as it attests the high-specific interferon release against the respective<br />

co-pathogen in the blood.<br />

It should be noted that in some cases it is the co-pathogen itself which is responsible for the<br />

symptoms and not the Borrelia infection: e.g. Chlamydia cause diseases patterns such as Morbus<br />

Alzheimer, Multiple Sclerosis, fibromyalgia, Chronic Fatigue Syndrome (CFS), myocardinal<br />

infarcts, strokes, vasculitides, visual disturbances.<br />

The Lyme infection may well have been treated successfully with antibiotics, but the co-infection<br />

might not have been destroyed by it. Therefore, an exact anamnestic documentation of the<br />

symptoms during the therapy is necessary before, during and after a Borrelia infection.<br />

Further information regarding the importance of co-infections can be fo<strong>und</strong> in the separate<br />

information for patients: „Increasing importance of co-infections for Lyme disease patients” (article<br />

by Armin Schwarzbach, M.D., PhD).<br />

<strong>Labor</strong>atory transmittals<br />

In case of a suspected tick-borne disease physicians have the opportunity to execute specific<br />

laboratory analyses in cooperation with the <strong>BCA</strong>. The blood kits contain special anamnestic<br />

questionnaires by the <strong>BCA</strong> and a questionnaire to check for co-infections. The patient should fill<br />

out these questionnaires and send them to the <strong>BCA</strong> together with the blood kits.<br />

We are delighted to provide interested physicians with further information about possibilities in<br />

terms of collaboration and co-operation to provide a successful treatment for patients suffering<br />

from tick-borne diseases. Especially for the diagnosis and therapy of chronically ill patients, who<br />

are not living in the Augsburg area we can coordinate the procedure of the treatment with the<br />

attending physician at home if wanted. However, in case of complicated symptoms and severe<br />

illness patterns we recommend the physicians of the Medical Partnership which cooperates with<br />

the <strong>BCA</strong> for the first diagnosis and therapy plan preparation. We also recommend the Lyme


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 6<br />

Disease “Intensive Treatment and Rehabilitation” Program of the <strong>BCA</strong>, which is a special Compact<br />

Treatment <strong>clinic</strong> for chronically ill patients here in Augsburg.<br />

The <strong>BCA</strong> regularly offers seminars and workshops, as well as exchange and sharing of<br />

experiences to interested physicians and cooperation partners.<br />

Below you will find as attachments further information regarding the laboratory tests on the<br />

cellular level (Borrelia Elispot ® -LTT, CD3-/CD57+ cells and the Elispots for Chlamydia and<br />

Ehrlichia) as well as the order form for laboratory tests with declaration of consent for the <strong>BCA</strong>.<br />

<strong>Diagnostik</strong> Diagnostis + Therapie Therapy<br />

„Ä „ Medical rztliche<br />

Partnerschaft Partnership“ “ *<br />

- 9 4 behandelnde attending phisicians Ärzte -<br />

f ü r alle for medizinischen<br />

all medical<br />

Leistungen services<br />

Dr. med. C. Nicolaus, praktischer Arzt,<br />

& Dr. med. A. Schwarzbach, <strong>Labor</strong>arzt,<br />

ä rztliche Partnerschaft f ü r zecken -<br />

ü bertragene Erkrankungen *<br />

Attachments<br />

unterst Accompanying ü tzende<br />

Therapies - Therapien<br />

spezialisiertes<br />

Specialized<br />

<strong>Labor</strong>atory <strong>Labor</strong><br />

inkl. Incl. Intensivbehandlung Chronic Lyme u. fü r Zeckenü for tick-borne bertragene<br />

Compact Ganztagesbetreuung Treatment Erkrankungen diseases an co-infections (<strong>Borreliose</strong><br />

(spezielles (special weekly Wochenprogramm program <strong>und</strong> das breite Spektrum der<br />

for fü lyme disease patients Co -Infektionen)<br />

B - C- A <strong>Borreliose</strong> Centrum Augsburg Betriebs GmbH & Co. KG<br />

( www.B - C - A.de )<br />

• Further information regarding the laboratory tests on cellular levels: Borrelia Elispot ® -LTT,<br />

CD3-/CD57+ cells, Chlamydia Elispot ® -LTT and Ehrlichia Elispot ® -LTT<br />

• Order form for laboratory tests with declaration of consent<br />

Note Range of Services:<br />

• All medical services (diagnosis, therapies,<br />

therapy plans and medical therapy<br />

monitoring) are provided by the attending<br />

physicians of the „Medical Partnership“ will<br />

be billed to the patient on a private medical<br />

basis (according to the Medical Association’s<br />

professional code of conduct in Bavaria).<br />

• All laboratory services will be billed from<br />

<strong>BCA</strong>-<strong>clinic</strong> Betriebs GmbH & Co. KG<br />

Borrelia Elispot ® -LTT<br />

- Determination of actual activity in the blood regarding Borrelia burgdorferi<br />

A Borrelia infection simultaneously leads to an activation of T-lymphocytes lateral to the humoral<br />

immune response. The T-cellular immune answer vanishes as soon as the Lyme disease infection<br />

is not active anymore.<br />

A control of success of a Lyme infection therapy is not possible via Borrelia antibodies, as the<br />

“titer” or the antibodies can still be fo<strong>und</strong> in the blood for years after a cured infection. Additionally,<br />

in the first stage of Lyme disease (e.g. “bull´s eye rash” or “summer flu” after a tick bite) antibodies<br />

can only be detected and measured after several weeks or not at all.<br />

The diagnostic gaps are suggested to be Borrelia according to the Elispot, which measures the<br />

actual activity regarding Borrelia burgdorferi with chronic and also acute Lyme disease infections.<br />

The Elispot is so sensitive, that it can even detect a single Borrelia reactive T-cell in the blood. The<br />

Elispot is 20- to 200-fold more sensitive than an ELISA-test on Borrelia and is able to find 1<br />

reactive cell <strong>und</strong>er 100.000 lymphocytes.<br />

The Elispot of Borrelia is very important for controlling a therapy of a chronic or acute Lyme<br />

infection. In general the Elispot is negative approximately 6 to 8 weeks after the end of a<br />

successful therapy.


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 7<br />

Advantages of the Borrelia Elispot-LTT (- as performed in the <strong>BCA</strong> -) in contrast to traditional<br />

lymphocyte transformation tests:<br />

• The result is obtainable within 2 days (LTT: 1 – 2 weeks) !<br />

• The use of cell stabilising CPDA tubes means a stability of 3 days for the measured cells<br />

(LTT: Heparin blood only 24 hours) !<br />

This offers a significant improvement of the stability of the examined cells and a fast decisionmaking<br />

possibility for Lyme disease therapists to extend the duration of a therapy or start a new<br />

treatment approach!<br />

Borrelia Elispot:<br />

Materials: 2 x 8.5 ml CPDA-tubes (kept at room temperature, do not refrigerate)<br />

Time required for analysis: 2 days<br />

Billing according to GOÄ: Number 3694 (3 different antigen approaches) factor 1.5 (3x<br />

49.84 €) + number 4003 (Lymphocytes isolation) Factor 1.5 (34.97 €)<br />

- total sum: 184.49 €<br />

Indications:<br />

- Diagnosis of a chronic Lyme disease<br />

- Diagnosis of a acute Lyme disease<br />

- Decision-making regarding the length of therapy<br />

- Control of therapy after a Lyme disease therapy<br />

Borrelia CD 57+ cells<br />

- Determination of chronic activity in the blood regarding Borrelia burgdorferi<br />

A chronic progression (stage III) of a Lyme infection leads to a weakening of the immune system.<br />

This is reflected by the decrease of the CD3-/CD57+ NK-cells in case of chronic Lyme disease.<br />

The CD3-/CD57+ cells are a subpopulation of the Natural-Killer-Cells (NK-cells).<br />

A decrease of the CD57+ cells indicates (an untreated) chronic or not sufficiently treated chronic<br />

Lyme disease and does not appear in cases of a acute Lyme infection (e.g. “bull’s eye rash“ or<br />

“summer flu“ after a tick bite).<br />

The CD57+ cells reflect the degree of activity of a chronic Lyme disease and decrease to a normal<br />

level after a successful Lyme disease therapy (after the end of treatment).<br />

In contrast there is no decrease of CD57+ cells with <strong>clinic</strong>al similar diseases, such as Multiple<br />

Sclerosis (MS), Systemic Lupus Erythematosus (SLE) or an Amyotrophic Lateral Sclerosis (ALS).<br />

In addition there is no significant fluctuation of CD57+ cells throughout the day.<br />

CD57+ cells are appropriate laboratory parameters in cases where chronic Lyme disease is<br />

suspected and for therapy monitoring. These should be measured parallel to the Borrelia Elispot,<br />

which reflects the actual T-cellular activity.<br />

Advantages of the CD57+ cells determination of Borrelia:<br />

1. The result is available within 2 days !<br />

2. The use of cell-stabilising Heparin-tubes assures a stability of the measured NK-cells for 2<br />

days!<br />

In combination with the Borrelia Elispot this results in a significant improvement of the stability of<br />

the examined cells and a fast decision-making possibility for Lyme disease therapists to extend<br />

the duration of a therapy or start a new treatment approach!<br />

CD3-/CD57+ NK-cells:Material: 1 x 10 ml Heparin-tube + 1 x EDTA-blood/blood count-tube (kept<br />

at room temperature, do not refrigerate)<br />

Time required for analysis: 2 days


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 8<br />

Billing according to GOÄ: Number 3696 x 2, factor 1.5 (99.68 €) + number 3550/3551 (big<br />

blood picture), factor 1.5 (6.99 €), total sum: 106,68 €<br />

Indications:<br />

- Diagnosis of chronic Lyme disease<br />

- Decision-making regarding length of therapy<br />

- Control of therapy after a Lyme therapy<br />

Chlamydia Elispot ® -LTT<br />

- Determination of actual Chlamydia activity in the blood<br />

Chlamydiae are intracellular pathogens, which can be the reason for various medical conditions.<br />

There are two sub species: Chlamydia pneumoniae and Chlymydia trachomatis.<br />

Chlamydia pneumoniae is mainly an airborne infection and is transmitted from humans to humans.<br />

Chlamydia pneumoniae has a very high degree of penetration. The following ailment patterns are<br />

associated with the disease: e.g. inflammation of joints, tendonitis, Multiple Sclerosis, fibromyalgia,<br />

Morbus Alzheimer, chronic fatigue syndrome (CFS), arteriosclerosis. An immune suppression is a<br />

risk factor for Chlamydia infections amongst others also for chronic infections, such as Lyme<br />

disease.<br />

Chlamydia trachomatis is transmitted sexually from humans to humans and causes the following<br />

medical conditions: sterility, urethritis and cervical inflammation, acute conjunctivitis (“swimming<br />

pool conjunctivitis”), inflammation of joints and tendonitis after the infection. An immune<br />

suppression is a risk factor here as well.<br />

A Chlamydia infection leads to an activation of the T-lymphocytes parallel to the humoral immune<br />

answer (Chlamydia IgG- and Chlamydia IgA-antibodies). The T- cellular immune answer vanishes<br />

as soon as the Chlamydia infection shows no activity.<br />

The Elispot on Chlamydia trachomatis or Chlamydia pneumoniae therefore shows the actual<br />

activity of these diseases. The Chlamydia pneumoniae- and Chlamydia trachomatis-Elispot helps<br />

with the diagnosis of these infections and also is a means of successful control during the course<br />

of the therapy.<br />

Advantages of the Chlamydia Elispot:<br />

• The result is available within 2 days !<br />

• The use of cell-stabilising CPDA tubes means a stability of up to 3 days for the measured<br />

T-cells !<br />

• The right choice of a specific antibiotic therapy !<br />

Chlamydia pneumoniae and/or Chlamydia trachomatis Elispot:<br />

Material: 2 x 8.5 ml CPDA-tubes (kept at room temperature, do not refrigerate)<br />

Time required for analysis: 2 days<br />

Billing according to GOÄ (single price for Chl. Pneumoniae/ Chl. Trachomatis):<br />

Number 3694, factor 1.5 (49.84 €) + number 4003 (lymphocytes isolation), factor 1.5<br />

(34.97 €), sum for single test: 84.81 €<br />

Indications:<br />

- Diagnosis of a Chlamydia infection<br />

- Decision-making regarding length of therapy<br />

- Control of therapy success after a Chlamydia-specific therapy


Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 9<br />

Ehrlichia/Anaplasma Elispot ® -LTT<br />

- Determination of actual activity in the blood regarding Ehrlichia/Anaplasma<br />

Ehrlichia or Anaplasma are intracellular pathogens, which can be fo<strong>und</strong> obligatory within the white<br />

blood cells. Ehrlichia are transmitted to the human by ticks contaminated with Ehrlichia<br />

(approximately 6% of all ticks are contaminated with the pathogen).<br />

The symptoms of an Ehrlichia infection begin with flu like problems and express themselves with<br />

strong headache, which are very often located “behind the eyes”. Furthermore muscle aches and<br />

numerous neurologic symptoms may be caused by Ehrlichia. Rarely skin rashes on various parts<br />

of the skin can be fo<strong>und</strong>, also on the palm of the hand and soles of the feet.<br />

An immune suppression is often the risk factor for an Ehrlichia infection amongst others<br />

depending on age, but also on chronic infections like Lyme disease.<br />

In the case that Ehrlichiosis (illness pattern of an infection with Ehrlichia) existing parallel to a<br />

Lyme infection it is called co-infection. According to the latest scientific literature additional coinfections<br />

with Ehrlichia should be taken into account in ca. 30% of all chronic Lyme disease<br />

patients.<br />

An infection with Ehrlichia leads to an activation of the T-lymphocytes parallel to the humoral<br />

immune answer (Ehrlichia-IgM- and Ehrlichia-IgG-antibodies). The T-cellular immune answer<br />

vanishes as soon as the Ehrlichia infection shows no activity.<br />

The Elispot on Ehrlichia/Anaplasma measures the actual activity of this disease.<br />

The Ehrlichia-Elispot helps with the diagnosis of this infection and also is a means of a successful<br />

control during the course of the therapy.<br />

Advantages of the Ehrlichia Elispot:<br />

• The result is available within 2 days !<br />

• The use of cell stabilising CPDA tubes means a stability of up to 3 days for the measured<br />

T-cells !<br />

• The right choice of a specific antibiotic therapy !<br />

Ehrlichia Elispot:<br />

Material: 2 x 8.5 ml CPDA-tubes (kept at room temperature, do not refrigerate)<br />

Time required for analysis: 2 days<br />

Billing according to GOÄ: Number 3694, factor 1.5 (49.84 €) + number 4003 (lymphocytes<br />

isolation), factor 1.5 (34.97 €), total sum 84.81 €<br />

Indications: - Diagnosis of an infection with Ehrlichia<br />

- Decision-making regarding the length of therapy<br />

- Control of therapy success after an Ehrlichia-specific therapy<br />

Attachment: Order form for laboratory tests with declaration of consent<br />

- This order is to be filled out by your physician and has to be signed and dated by you in case of<br />

an order to the infectolab laboratory. The costs of the respective laboratory order result from the<br />

following individual prices (GOÄ), plus possible side costs for blood sampling, blood tubes,<br />

shipment.


Patient’s last name, first name Date of birth<br />

<strong>Labor</strong>atory Tests Order Form<br />

Please write in CAPITAL LETTERS Male □ Female □<br />

House No., Street<br />

Post Code/ZIP City Country/State<br />

Phone Email<br />

Ihr kompetenter <strong>Labor</strong>partner<br />

Seite 10<br />

Please forward my test results to my home/family doctor<br />

(name, address of doctor’s practice)<br />

House No., Street<br />

Post Code/ZIP City Country/State<br />

Phone and Fax or Email<br />

I would like the following laboratory parameters (diagnostics) to be tested:<br />

Euro € Euro € Euro<br />

€<br />

o Borrelia Elispot LTT 184.49 o Chlamydia pneumoniae Elispot LTT 84.81 o CCP- Antibodies 39.34<br />

(CPDA) (CPDA) (Serum)<br />

o CD3-/CD57+ Cells 106.68 o Chlamydia pneumoniae-Antibodies 61.20 o ANA-Titer (Serum) 44.60<br />

(Heparin+EDTA) (Serum) o ENA-Screening (Serum) 157.38<br />

o Borrelia IgG- and IgM-EIA 69.07 o Chlamydia trachomatis Elispot LTT 84.81 o ds-DNS- Antibodies<br />

(Serum)<br />

44.60<br />

(Serum) (CPDA) o c- <strong>und</strong> p-ANCA (Serum) 89.19<br />

o Borrelia IgG- and IgM-Blot 139.88 o Chlamydia trachomatis-Antibodies 61.20 o CRP (Serum) 17.49<br />

(Serum) (Serum) o “Diarrhoea/Coeliac Profile“ 97.04<br />

o Borrelia-DNA-PCR 148.63 o Mycoplasma-Antibodies 123.27 (Gliadin-IgA-Antibodies,<br />

(EDTA,Blood Urine, Aspirate,<br />

Biopsy)<br />

(Serum) Tissue transglutaminase-IgGo<br />

Ehrlichia Elispot LTT 84.81 o Yersinia IgG- <strong>und</strong> IgA-Blot 139.88 Antibodies, total IgA)<br />

(CPDA) (Serum)<br />

o Ehrlichia-IgM- and IgG Antibodies 89.19 o Rickettsia-IgG-Antibodies 89.19 o “Organ Profile“ 86.58<br />

(Serum) (Serum) (Full Blood Count, GOT, GPT,<br />

o Ehrlichia-DNA-PCR 174.87 o Rickettsia-DNA-PCR 218.58 GGT, LDH, Che, Bilirubin<br />

(EDTA) (EDTA) total, Amylase, Lipase, CK,<br />

o Bartonella-IgG Antibodies 89.19 o EBV-Antibodies 110.17 Creatinine, Urea, Sodium,<br />

(Serum) (Serum) Potassium, TSH basal, Quick,<br />

o Bartonella-DNA-PCR 174.87 o HSV- Antibodies 41.97 PTT, AP)<br />

(EDTA) (Serum) o Protein (Serum) 20.11<br />

o Babesia-IgG-Antibodies 44.60 o CMV- Antibodies 47.22 (Total + Electrophoresis)<br />

(Serum) (Serum) o Lipids (test on empty stomach) 14.00<br />

o Babesia-DNA-PCR 174.87 o Toxoplasmosis- Antibodies 82.19 (Cholesterol, Triglyceride,<br />

(EDTA) (Serum) HDL, LDL)<br />

Please always take 2 CPDA tubes o Coxsackie- Antibodies 120.67 o Thyroid Gland (Serum) 65.58<br />

of blood for the Elispot LTT!!! (Serum) (TSH basal, fT3, fT4)<br />

o Thyroid-Antibodies<br />

(Serum) (MAK,TAK,TRAK)<br />

126.77<br />

o Heavy-Metals-Testing<br />

From Urine in case of Lyme<br />

(Aluminium,Cadmium, Lead,<br />

Mercury, Copper, Creatinine)<br />

182.75<br />

o Other Tests:<br />

……………………………………………………………………………………………………………………………………………………………………<br />

Declaration of Consent:<br />

I herewith declare that I am fully insured by a compulsory medical health insurance company. I also acknowledge that the insurance<br />

company, which I am insured with, provides sufficient cover for medical treatment and diagnostics. I wish to receive further medical<br />

services, which might not be included in my insurance cover, and accept laboratory services with factor 1.5<br />

I am aware that I have to pay the costs for laboratory tests myself, and that I will receive an invoice from the <strong>Borreliose</strong> Centrum<br />

Augsburg for any <strong>und</strong>ertaken laboratory tests. I am aware of the costs for all laboratory parameters I wish to be tested. The test<br />

results will be send to my doctor (either at the <strong>BCA</strong> or my family doctor at home).<br />

I agree that all laboratory parameters will be tested in and invoiced by the <strong>Borreliose</strong> Centrum Augsburg according to the German<br />

Medical Fee Schedule (GOÄ 3500-4787, factor 1.5). Furthermore, I agree to send a pre-payment for all laboratory tests in advance.<br />

Results will not be send out until the full invoice is paid.<br />

Date, Signature: ………………………………………………………………………………………….………

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